Procrit 4,000 U/ml 1ml Sd Vial
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein by a healthcare professional.
Self-Administration
If you are giving yourself the injection, your doctor or nurse will instruct you on the proper technique. It is essential to follow their guidance to ensure safe and effective use.
Important Handling Instructions
Do not shake the medication.
Do not use the medication if it has been shaken.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles.
Check the solution for any color changes; do not use if the color has changed.
Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposal of Needles and Sharps
Dispose of used needles and sharps in a designated disposal box.
Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Follow the storage instructions provided for all products.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain adequate iron intake as prescribed by your doctor (often requires iron supplements).
- Monitor your blood pressure regularly at home, as this medication can raise it.
- Report any unusual symptoms immediately to your healthcare provider.
- Do not stop taking the medication without consulting your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Rapid heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Extreme fatigue or weakness
Pale skin
Depression
If you experience any of the following symptoms, call your doctor right away, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Difficulty speaking or swallowing
In rare cases, a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems and even death. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Irritation at the injection site
Fever or chills
Headache
Upset stomach or vomiting
Cough
Bone, joint, or muscle pain
Muscle spasms
Mouth irritation or mouth sores
Weight loss
Sleep disturbances
* Common cold symptoms
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden chest pain or shortness of breath
- Sudden numbness or weakness on one side of the body
- Sudden severe headache or vision changes
- Swelling, pain, or redness in an arm or leg (signs of a blood clot)
- Unusual tiredness or paleness that suddenly worsens (signs of PRCA)
- Severe allergic reaction (rash, hives, difficulty breathing, swelling of face/throat)
- Signs of high blood pressure (severe headache, blurred vision, dizziness)
Before Using This Medicine
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you have high blood pressure.
If you have active bleeding.
If you have low levels of vitamins or minerals.
If you have a condition called Pure Red Cell Aplasia (PRCA), a type of anemia.
Additionally, if you are using a multi-dose container, tell your doctor:
If you are pregnant or think you might be pregnant. This medication is not recommended during pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication and for 2 weeks after your last dose.
If the patient is a premature baby or newborn. This form of the medication is not suitable for premature babies or newborns.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health problems. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is derived from human plasma, which is a component of blood, and may potentially contain viruses that can cause disease. Although this medication is thoroughly screened, tested, and treated to minimize the risk of infection, it is crucial to discuss this with your doctor.
Monitoring and Precautions
Regular blood pressure checks are necessary while taking this medication, as it may cause high blood pressure. Adhere to your doctor's instructions for monitoring your blood pressure. Additionally, your doctor may require regular blood tests to ensure safe treatment. It is vital to follow your doctor's guidance on blood work and discuss any concerns with them.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more of this medication than directed, contact your doctor immediately.
Risks and Abuse
This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult your doctor.
Specific Product Warnings
Multi-dose container: This product contains benzyl alcohol, which can cause serious side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. Whenever possible, avoid using products with benzyl alcohol in these age groups. If you have questions, discuss them with your doctor.
Single-use vial: If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count), which can lead to hyperviscosity syndrome and increased risk of thrombotic events (e.g., stroke, heart attack).
What to Do:
Discontinue epoetin alfa. If polycythemia is severe, phlebotomy (blood removal) may be performed to reduce hematocrit. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Thalidomide
- Lenalidomide
- Pomalidomide
Monitoring
Baseline Monitoring
Rationale: To establish baseline anemia severity and guide initial dosing.
Timing: Prior to initiation of therapy.
Rationale: Adequate iron stores are essential for optimal erythropoiesis and response to epoetin alfa. Iron deficiency is a common cause of ESA hyporesponsiveness.
Timing: Prior to initiation of therapy.
Rationale: Epoetin alfa can cause or exacerbate hypertension.
Timing: Prior to initiation of therapy.
Rationale: To assess overall hematologic status and rule out other causes of anemia.
Timing: Prior to initiation of therapy.
Rationale: To assess kidney disease severity and guide dosing in CKD patients.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Weekly or bi-weekly until stable, then monthly.
Target: 10-11 g/dL (CKD); <10 g/dL (chemotherapy-induced anemia). Avoid exceeding 11 g/dL (CKD) or 10 g/dL (chemotherapy-induced anemia).
Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or approaches target, reduce dose. If Hb falls or does not increase, increase dose after ruling out other causes of anemia.
Frequency: Monthly or quarterly, or as clinically indicated.
Target: Ferritin >100 ng/mL (CKD), >30 ng/mL (non-CKD); TSAT >20%.
Action Threshold: If iron stores are low, initiate or increase iron supplementation.
Frequency: Regularly (e.g., weekly or bi-weekly) during dose titration, then as per clinical practice.
Target: Individualized, typically <140/90 mmHg.
Action Threshold: If BP increases, initiate or intensify antihypertensive therapy. If uncontrolled, consider dose reduction or temporary interruption of epoetin alfa.
Frequency: Periodically, especially in CKD patients.
Target: 3.5-5.0 mEq/L
Action Threshold: Monitor for hyperkalemia, which can occur with rapid increases in erythropoiesis.
Symptom Monitoring
- Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, sudden numbness or weakness, vision changes, swelling/pain in leg)
- Signs and symptoms of severe allergic reactions (e.g., rash, urticaria, dyspnea, wheezing, hypotension)
- Signs and symptoms of Pure Red Cell Aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
- Signs and symptoms of uncontrolled hypertension (e.g., severe headache, blurred vision, confusion, seizures)
- Signs and symptoms of tumor progression or recurrence (in cancer patients)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Human data are limited.
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). Epoetin alfa is present in human milk. Consider the developmental and health benefits of breastfeeding, the motherβs clinical need for epoetin alfa, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Oral absorption by the infant is unlikely due to the large protein nature of the drug.
Pediatric Use
Approved for anemia associated with CKD in pediatric patients. Dosing is weight-based. Safety and efficacy in pediatric patients with chemotherapy-induced anemia or HIV-associated anemia have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more sensitive to the effects of epoetin alfa, particularly regarding cardiovascular events. Dose titration should be cautious.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores (ferritin >100 ng/mL, TSAT >20%) before and during epoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- Do not target hemoglobin levels above 11 g/dL in CKD patients or 10 g/dL in cancer patients due to increased risks of serious adverse events.
- Monitor blood pressure closely, especially during the initial phase of therapy, as hypertension is a common side effect.
- If a patient becomes resistant to epoetin alfa, investigate other causes of anemia (e.g., iron deficiency, inflammation, infection, blood loss, vitamin deficiencies, PRCA).
- Administer subcutaneously for most indications outside of hemodialysis patients, as it allows for less frequent dosing and comparable efficacy.
- Patients should be educated on the signs and symptoms of blood clots and instructed to seek immediate medical attention if they occur.
Alternative Therapies
- Darbepoetin alfa (Aranesp) - longer-acting ESA
- Methoxy polyethylene glycol-epoetin beta (Mircera) - very long-acting ESA
- Iron supplementation (oral or IV) - often used adjunctively
- Blood transfusions - for acute, severe anemia or when ESAs are contraindicated/ineffective
- Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) like Roxadustat (Evrenzo) - newer class for CKD anemia (not yet widely available in all regions)
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.